Loma Vista Medical Inc.

Article preview from Start-Up - June, 2012

With the clinical literature documenting the structural failure rate of standard balloon catheters for balloon aortic valvuloplasty and transcatheter aortic valve implantation hovering between 10 and 17%, there is definitely a need for a more durable balloon to prevent puncturing or bursting. Loma Vista Medical Inc. thinks its recently launched TRUE Dilatation balloon meets the unique requirements of TAVI. It is made of high-strength bulletproof fibers (a composite of seven different materials/layers) that are more effective than any one material alone and are ideal to handle high-structural loads.

Loma Vista Medical Inc.

Article preview from Start-Up - June, 2012

With the clinical literature documenting the structural failure rate of standard balloon catheters for balloon aortic valvuloplasty (BAV) and transcatheter aortic valve implantation (TAVI) hovering between 10 and 17%, there is definitely a need for a more durable balloon to prevent puncturing or bursting. “This is the highest structural failure rate for any balloon for any clinical indication in the body,” states Alex Tilson, president and CEO of Loma Vista Medical Inc., which recently launched the TRUE Dilatation balloon valvuloplasty catheter. “Ours is the first balloon that fits the unique requirements of TAVI.”

TAVI balloons are large-diameter balloons that expand at high pressure inside the aortic valve. Additionally, the aortic valve can have sharp nodules (calcifications) that often puncture the balloon. “These factors conspire to make it a very difficult environment for a traditional blow-molded balloon,” Tilson says. In contrast, the TRUE Dilatation balloon is made of high-strength bulletproof fibers (a composite of seven different materials/layers) that are more effective than any one material alone and are ideal for handling high-structural loads. Of the approximately 100 cases performed to date with the device, there has not been a single structural failure, Tilson reports.

Currently, TAVI represents roughly 20,000 cases annually in the world, mostly in Europe. The first commercial US case occurred in November. But by the end of this decade, the number of cases worldwide is expected to grow by seven- to 10-fold, reaching anywhere from 120,000 to 200,000 cases yearly. During that same time period, the potential market cap for TRUE Dilatation could also grow from $10 million to over $100 million.

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